PEDIAPRED (prednisolone sodium phosphate) · PAI HOLDINGS PHARM
Pediapred (prednisolone sodium phosphate) is an oral glucocorticoid solution indicated for the management of a broad spectrum of endocrine, inflammatory, and autoimmune disorders in adult and pediatric patients. It is primarily used for severe or recalcitrant allergic states (e.g., asthma, contact dermatitis), dermatologic diseases (e.g., pemphigus, Stevens-Johnson syndrome), and respiratory conditions (e.g., sarcoidosis). Additionally, it is indicated for the treatment of neoplastic diseases (leukemias and lymphomas), hematologic disorders (e.g., idiopathic thrombocytopenic purpura), gastrointestinal diseases (e.g., ulcerative colitis), and to induce diuresis in nephrotic syndrome.
How PEDIAPRED Works
Prednisolone is a synthetic glucocorticoid that exerts potent anti-inflammatory and immunomodulatory effects. It diffuses across cell membranes and binds with high affinity to cytoplasmic glucocorticoid receptors (GR). The resulting ligand-receptor complex translocates to the nucleus, where it binds to specific DNA sequences called glucocorticoid response elements (GREs). This interaction modulates gene transcription, leading to the induction of anti-inflammatory proteins (such as lipocortin-1, which inhibits phospholipase A2) and the transrepression of pro-inflammatory transcription factors, including NF-κB and AP-1. These actions result in decreased production of inflammatory mediators (cytokines, interleukins, prostaglandins, and leukotrienes), reduced capillary permeability, and suppression of the humoral and cell-mediated immune responses.
Details
- Status
- Prescription
- First Approved
- 1986-05-28
- Routes
- ORAL
- Dosage Forms
- SOLUTION
PEDIAPRED Approval History
What PEDIAPRED Treats
23 indicationsPEDIAPRED is approved for 23 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Rhinitis
- Asthma
- Contact Dermatitis
- Atopic Dermatitis
- Serum Sickness
- Drug Hypersensitivity
- Pemphigus
- Dermatitis Herpetiformis
- Erythema Multiforme
- Exfoliative Erythroderma
- Mycosis Fungoides
- Nephrotic Syndrome
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Thyroiditis
- Ulcerative Colitis
- Idiopathic Thrombocytopenic Purpura
- Thrombocytopenia
- Hemolytic Anemia
- Pure Red Cell Aplasia
- Diamond-Blackfan Anemia
- Acute Leukemia
- Lymphoma
PEDIAPRED Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PEDIAPRED's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PEDIAPRED treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PEDIAPRED
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03484507 | UCSF-IRB-17-23895 | Ph 2 | completed | Parasitic Ulcer Treatment Trial Pilot |
| NCT05444699 RhinoPOCRCT | OY102021 2024-512561-13-00, 2021-006050-31 | Ph 4 | recruiting | Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age |
| NCT03698630 | RESP_301_2010 2010-022001-18, ISRCTN26944158 | Ph 4 | completed | Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PEDIAPRED FDA Label Details
Indications & Usage
FDA Label (PDF)Prednisolone Sodium Phosphate Oral Solution is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States To induce diur...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.